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Comperative efficacy and safety of a microneedle patch for the improvement of the nasolabial fold

Phase 1
Completed
Conditions
Facial wrinkle in the nasolabial folds area
skin aging, nasolabial fold, rejuvenation, microneedle patch, microneedling
Registration Number
TCTR20231008001
Lead Sponsor
Thammasat University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
36
Inclusion Criteria

1.Female patient age between 20-60 years old
2.Mild to moderate nasolabial folds according to the Merz Aesthetics Scale

Exclusion Criteria

1.Patient refuses to participate in the study
2.Pregnancy or lactation
3.History of energy base device treatment within 1 year
4.History of laser therapy within 6 months
5.History of chemical peeling within 1 month
6.History of mesotherapy injection at nasolabial folds within 1 month
7.History of Botox or filler injection at nasolabial folds within 1 year
8.History of taking antiplatelet and anticoagulants within 1 month
9.A current or prior history of infectious skin disease
10.A current or prior history of eczematous dermatitis on the face
11.A current or prior history of using immunosuppressive therapy
12.A current or prior history of allergy or hypersensitivity to polymethylmethacrylate (PMMA) and the monomer plastic
13.A current or prior history of collagen supplement
14.Other underlying that cosmetic affect their health condition

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of Nasolabial folds at 2 weeks interval for a total of 12 weeks Merz Aesthetics Scale
Secondary Outcome Measures
NameTimeMethod
Pain score At 2 weeks interval for a total of 12 weeks visual analog scale ,Skin elasticity At 2 weeks interval for a total of 12 weeks Cutometer,Skin roughness At 2 weeks interval for a total of 12 weeks Antera 3D,Participants satisfaction At 2 weeks interval for a total of 12 weeks Participants satisfaction score
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